Research Affairs (ORA)

Research Operations and Administrative Rounds (ROAR) meetings are conducted monthly by the Office of Research Affairs and collaborating offices (College of Medicine Clinical Trials Office, Controller’s Office, Research Quality Assurance, Center for Medical Innovation, Human Subjects Protection Office) to provide research adminstrators and clinical research study teams with time-sensitive information and policy/procedure updates related to research administration practices at Penn State College of Medicine and Penn State Health.

Upcoming ROAR Meetings

The primary mission of the Research Quality Assurance Office (RQA) is to support the planning and conduct of both clinical research and basic laboratory research being conducted at the Penn State College of Medicine.

Learn more about RQA

In addition to the Office of Research Affairs, a number of other entities across Penn State College of Medicine and the University are responsible for parts of the grants and contracts lifecycle.

See the full roles and responsibilities matrix

The College of Medicine and Penn State offer numerous methods to find grant, contract, foundation and internal funding opportunities.

Explore funding opportunities

Penn State College of Medicine has an addendum to Penn State’s Research Administration University Development (RAUD) Collaborative Procedures.

This addendum summarizes the process of handling gifts, charitable grants and unrestricted grants at the College of Medicine in accordance with University Policy RA04, Gifts, Grants and Contracts (The Funding Matrix).

See RAUD information for College of Medicine investigators

The investigator-initiated study support team’s goal is to attain the successful completion of investigator-initiated studies.

This includes providing information and direction for accessing University and College of Medicine resources for key study aspects such as:

• peer-review for scientific rigor,
• budgeting and identification of appropriate funding sources,
• providing guidance for completing application to the Institutional Review Board,
• assisting with intellectual property and inventions, and
• ensuring compliance with Penn State policies and procedures.

The investigator-initiated study support team members include staff from Office of Research Affairs, Clinical Trials Office, Clinical and Translational Science Institute, Center for Medical Innovation, Conflict of Interest, Research Quality Assurance and Human Subjects Protection Office.

The first step of the investigator-initiated study process is to provide the team with background on the project.

Request Research Project Help

Upon receiving the information, the investigator-initiated study support team and any other applicable offices will review responses and contact the project team with next steps.

Intent to Submit a Proposal information is submitted in REDCap. When opening REDCap using the link below, look for the ISP under “My Projects.”

File an Intent to Submit

ISP Tips

• When REDCap training is completed and access has been activated, begin to enter all upcoming grant submissions to external sponsors (grants that will be reviewed/submitted by the Office of Research Affairs).
• Do not enter LOIs or pre-applications at this time. Wait until it is known that the PI has been invited to submit a full proposal and then complete the ISP with the full proposal deadline.
• For multi-project grants (“P,” “U,” etc.), only enter one ISP.
• For Department of Defense full applications, enter the log number in the remarks section.
• For new incoming subawards, the sponsor deadline is the date the submitting institution needs the final documents. This will never be the prime sponsor deadline. It will always be a date in advance of the actual prime sponsor deadline.
• For non-competing continuations, i.e. RPPR (not final RPPR), the ISP Type of Submission is “Non­Competing Continuation” and the Funding Mechanism is “Other,” then specify type by entering RPPR.
• When sponsor is NIH, please type NIH. Do not spell out or use the specific NIH institute.
• New records for each upcoming grant are always “Pending.” The only time this should be changed would be to choose “Not Submitted” if a principal investigator changes their mind.
• If a principal investigator changes their mind after work has already been done and is not submitting at all, change from “Pending” to “Not Submitted” and enter reason in Remarks section.
• If a principal investigator changes their mind and is submitting a different type of grant (for instance, R21 instead of R01) or at a later date, do not create a new record; edit the existing record and add notes in Remarks section.
• For principal investigators with continuous submission, enter original sponsor deadline. Then edit the record to change the date to the anticipated submission date provided by the principal investigator. Enter notes in Remarks section.
• Once all information is entered into the ISP form, mark it as “Complete.” This applies to the record, not the grant. Marking it complete does not lock the user out or prevent any necessary edits in the future.

For questions or assistance, contact the appropriate grants officer.

To request an account for NIH eRA Commons, NSF FastLane and SIMS/IAF, email e-grants@pennstatehealth.psu.edu noting the type of account needed. Include the full name of the person who needs the account.

SIMS, Penn State’s Strategic Information Management System, provides reporting capabilities for sponsored research data and proposal budgeting tools for research administrators. Budgets are prepared in SIMS.

The Office also uses Cayuse, a web application designed to simplify the creation, review, approval and electronic submission of most federal grant proposals.

Learn how to create a SIMS budget and a Cayuse package

The electronic Internal Approval Form (IAF) is a required internal form used by the College of Medicine to provide a summary of pertinent administrative and fiscal information about a proposed sponsored project. The IAF is initiated by the department administrator after the SIMS budget is created.

Learn how to create an IAF

If applicable, proposals should be submitted to Proposal Central.

The contracts unit of the Office of Research Affairs is dedicated to facilitating collaborations with sponsors and is responsible for the negotiation and acceptance of:

• Industry- and foundation-sponsored basic science research agreements and amendments
• Industry- and foundation-sponsored clinical trial agreements and amendments
• Federally funded clinical trial subawards, subcontracts and amendments

See the appropriate contract negotiator by department.

It is the responsibility of the principal investigator to read and understand the terms and conditions of the agreements.

How to Submit

• Submit a non-disclosure request form (NDA)
• Submit a core facilities service agreement
• Submit an industry-sponsored basic science agreement
• Submit an industry-sponsored clinical trial agreement by completing an IAF based on the IAF submission instructions for an industry-sponsored clinical trial.
  • For industry-sponsored clinical trials, investigators must also complete a STAR submission. The Office of Research Affairs will be notified when that is complete and the agreement will be assigned to a contract negotiator, with the status available in SIMS.
• Submit an industry-sponsored contract extension request without additional funds

The Office of Research Affairs at Penn State College of Medicine oversees the process of issuing external subawards and subcontracts.

Learn about the outgoing subagreement process

Submit a Data Use Agreement (Incoming or Outgoing)

Non-Disclosure Agreements (NDA), also known as Confidentiality Agreements (CDA), Proprietary Information Agreements, Secrecy Agreements, etc., are commonly requested when two or more parties wish to enter into initial discussions about specific processes, methods or technology for the purpose of determining the potential for a future relationship.

For assistance with confidentiality agreements for grants or contracts, contact the Office of Research Affairs at e-contracts@pennstatehealth.psu.edu or call 717-531-4196.

Confidentiality agreements for intellectual property/licensing are handled through the Center for Medical Innovation.

Learn More and Submit a Confidentiality Agreement (CDA) for Grants or Contracts

Visiting Scholar Agreements (VSA) are commonly requested when an individual is visiting the College of Medicine from another institution or business for purposes including but not limited to, conducting research and collaborating on University projects.

In order to be considered for the Visiting Scholar program, the visitor must meet the following criteria:

• Stay at the College of Medicine for one (1) year or less;
• Have an affiliation with an external institution/business; and
• Receive financial support from an entity other than PSU. (NOTE: No PSU funds, including grant money, can be used to support the visit.)
• For more information about the Visiting Scholar program, please see these links:
  • Visiting Scholar Policy AC-01
  • Visiting Scholar Guidelines

For assistance with requesting a VSA, or to determine if this program is appropriate for your visitor, please contact the Office of Research Affairs at E-Contracts@pennstatehealth.psu.edu or call 717-531-4196.

Submit a Visiting Scholar Agreement

A number of resources are available for successful post-award management.

Financial Resources

• College of Medicine Approval for Incurring Pre-Award Costs (accessible in OneDrive; Penn State Access ID login required)
• NIH Guidelines for Grant Spending

Non-Financial Resources

• Checklists (accessible in OneDrive; Penn State Access ID login required)
  • Just-in-Time Checklist
  • Incoming Subaward Checklist
  • Outgoing Subaward Checklist
  • RPPR Checklist
  • F30 Dual Doctoral Degree Checklist
  • F31 Predoctoral Checklist
  • F32 Postdoctoral Checklist
  • SF424 Forms E Checklist
  • SF424 K01 Checklist
  • SF424 K08 Checklist
  • SF424 K23 Checklist
• CURE Grant Extension Request
• No-Cost Extension Request for Contracts
• No-Cost Extension Request for Grants
• NIH guidelines for grant spending
• NIH RPPR All-Personnel Report Guidelines
• NIH RPPR Instruction Guide
• Public Health Service Grant Non-Competing Continuing Progress Report Guidelines

Ensuring compliance with proper protocols is an important part of the research process. Several programs at the Penn State College of Medicine help with this oversight.

See Research Compliance Overview

Tools are listed alphabetically in each category.

Penn State Software Login Pages

• CATS IRB login
• IAF login (via SIMS)
• SIMS login
• STAR login

Forms

• College of Medicine Approval for Incurring Pre-Award Costs (accessible in OneDrive; Penn State Access ID login required)
• Confidentiality Agreement
• Core Facilities Service Agreement
• CURE Grant Extension Request
• Data Use Agreement (Incoming or Outgoing)
• FCOI Subaward Form A (accessible in OneDrive; Penn State Access ID login required)
• FCOI Subaward Form B (accessible in OneDrive; Penn State Access ID login required)
• FCOI Consultant Investigator Form A (accessible in OneDrive; Penn State Access ID login required)
• FCOI Consultant Investigator Form B (accessible in OneDrive; Penn State Access ID login required)
• Industry-Sponsored Basic Science Agreement Request
• Industry Sponsored No-Cost Extension Request for Contracts Amendment Required
• Industry-Sponsored No-Cost Extension Request for Contracts with No Firm End Date
• Intent to Submit a Proposal (ISP)
• Material Transfer Agreement
• No-Cost Extension Request for Grants
• Non-Disclosure Request
• Non-Penn State Health Researcher Guidance (accessible in OneDrive; Penn State Access ID login required)
• OVDRGS External Grant Minimal Effort Allocation Exception Form
• Visiting Scholar Agreement

Checklists

A number of checklists for award management are available in a OneDrive folder (Penn State Access ID login required).

This folder includes:

• Just-in-Time Checklist
• Incoming Subaward Checklist
• Outgoing Subaward Checklist
• RPPR Checklist
• F30 Dual Doctoral Degree Checklist
• F31 Predoctoral Checklist
• F32 Postdoctoral Checklist
• SF424 Forms H Checklist
• SF424 K01 Checklist
• SF424 K08 Checklist
• SF424 K23 Checklist

Incoming Penn State College of Medicine faculty engaged in research must complete specific tasks regarding funding, compliance, data, trainees, intellectual property, laboratory setup and more.

See the research support checklist for new faculty

Outgoing Penn State College of Medicine faculty engaged in research must complete specific tasks regarding funding, compliance, data, trainees, intellectual property, laboratory closeout and more.

See the research support checklist for departing faculty

Industry-sponsored clinical trial contracts, basic science contracts, non-disclosure/confidentiality agreements and data use agreements may ask for the following information. Parts in [brackets] should be filled in accordingly.

Binding Party for Clinical Trial Contracts and Data Use Agreements

The Pennsylvania State University and The Milton S. Hershey Medical Center (collectively “Institution”).

OR

The Pennsylvania State University and Penn State Health Community Medical Group (collectively “Institution”).

[Investigator name] will act on behalf of Institution as “Investigator.”

Binding Party for Basic Science Contracts and Non-Disclosure/Confidentiality Agreements

The Pennsylvania State University (“Institution”).

[Investigator name] will act on behalf of Institution as “Investigator.”

Address

500 University Dr.
P.O. Box 850
Mail Code H138
Hershey, PA 17033

Payments

• Checks should be made payable to The Pennsylvania State University.
• Tax ID is 24-6000376.
• Payment should be mailed to:
  • By U.S. Postal Service (standard mail):
    Penn State College of Medicine
    Controller’s Office
    P.O. Box 850
    Mail Code H157
    Hershey, PA 17033
    Attention: Erlee H. Meyers
  • By ground delivery (FedEx or UPS):
    Penn State College of Medicine
    P.O. Box 850
    Controller’s Office – Mail Code H157
    Hershey, PA 17033
    Attention: Erlee H. Meyers
• Forward copy of invoice or detailed remittance for each payment, and reference principal investigator and protocol/study number. If sending electronically, documentation should be emailed to Erlee Meyers at controller@pennstatehealth.psu.edu.

Notices

Any notices required to be given under this Agreement shall be in writing and delivered by overnight mail, first-class mail or fax addressed to the parties as follows:

For institution:

Office of Research Affairs, Room C1604
Penn College of Medicine/Penn State Health Milton S. Hershey Medical Center
P.O. Box 850
Mail Code H138
500 University Dr.
Hershey, PA 17033

717-531-4196 (phone)
717-531-0040 (fax)
e-contracts@pennstatehealth.psu.edu (email)

For institution’s principal investigator:

[Investigator Name]
Penn State College of Medicine/Penn State Health Milton S. Hershey Medical Center
Department of [Department Name]
500 University Dr.
Hershey, PA 17033

[email address] (email)

Contracts Address

Office of Research Affairs
Room C1604
Penn State College of Medicine
500 University Dr.
Hershey, PA 17033

717-531-4196 (phone)
717-531-0040 (fax)
e-contracts@pennstatehealth.psu.edu (email)

Authorized Signature Information: The Pennsylvania State University

• Name: Sara Thorndike
• Title: Senior Vice President for Finance & Business/Treasurer

Authorized Signature Information: Penn State Health Milton S. Hershey Medical Center

• Name: Peter C. Ostasewski, MBA
• Title: Interim Vice President and Chief Financial Officer, Penn State Health Milton S. Hershey Medical Center

Authorized Signature Information: Penn State Health

• Name: Paula M. Tinch, CPA, PAHM
• Title: Senior Vice President and Chief Financial Officer

Authorized Signature Information: Penn State Health Community Medical Group, LLC

• Name: Stephen Massini
• Title: Secretary/Treasurer

Assurance Information

Human subjects assurances

• Get updated Federal Wide Assurance (FWA) information from the IRB/HSPO.

Authorized Signature Information: The Pennsylvania State University

• Name: Sara Thorndike
• Title: Senior Vice President for Finance & Business/Treasurer

Authorized Signature Information: Penn State Health Milton S. Hershey Medical Center

• Name: Peter C. Ostasewski, MBA
• Title: Interim Vice President and Chief Financial Officer, Penn State Health Milton S. Hershey Medical Center

Authorized Signature Information: Penn State Health

• Name: Paula M. Tinch, CPA, PAHM
• Title: Senior Vice President and Chief Financial Officer

Authorized Signature Information: Penn State Health Community Medical Group, LLC

• Name: Stephen Massini
• Title: Secretary/Treasurer

Authorized Signature Information: Proposals

• Name: Sheila L. Vrana, PhD
• Title: Associate Dean for Research

• Name: Thomas Brydebell
• Title: Director, Grants Administration

• Name: Kristi Bracale
• Title: Assistant Director, Grants Administration

Frequently Used Numbers

• Federal ID – Penn State Health Milton S. Hershey Medical Center: 25-1854772
• Federal ID – The Pennsylvania State University: 24-6000376
• Federal ID – For NIH Applications: 1246000376A3
• Legal Name for All Federal Applications: Pennsylvania State Univ Hershey Med Ctr
• Congressional District: PA-010
• DUNS Number: 129348186
• NAICS Code: 611310 (special instructions: use instead of SIC Code for Small Business Program Reps and Certs)
• CAGE Code: 7W765
• Commonwealth of PA Vendor ID: 141597-011
• CEC Number: 00-340-3953-62-174-881D
• NRC: 37-13831-01
• NSF Code: 0068130000
• FICE Code: 006813
• Federal Unique Entity Identifier (UEI): UEI TNKGNDAWB445

Assurance Information

Human subjects assurances

• Get updated Federal Wide Assurance (FWA) information from the IRB/HSPO.

Animal PHS assurances

• Assurance number: D16-00024 (A3045-01)
• Effective through: 07/31/2026
• Signatory official: Sheila Vrana, PhD

Frequently Used Dates

• Agreement with ONR for F&A: 01/05/2023
  Cognizant Agency Information – Office of Naval Research (ONR), Chicago Office, Phone: 312-886-5423
• AAALAC Approval Date: 03/16/2018

Salary Cap

• Executive Level II: $212,100
• Awards Effective: 01/01/2023

Press Contact/PR Official

• Name: Rachel Kostelac
• Title: Communications Manager
• Email: rkostelac@pennstatehealth.psu.edu

Revisions

Last revision: May 2, 2024

When working with Department of Defense submissions, these tips and reminders can help prevent common errors.

Key Points

• LOIs must list Thomas Brydebell as Business Official using e-grants@pennstatehealth.psu.edu.
• The firm submission deadline is 5 p.m. on deadline day. The Office of Research Affairs does not support submissions after this time.
• Different types of Department of Defense applications have varied components and requirements; they are not all the same. Investigators and submitters are encouraged to read them very closely.
• Pay attention to “blind” application requirements, where no reference to the principal investigator (or anything that identifies the PI) is allowed.
• The email address used in the pre-application and full application must match the PI’s email used to register in eBRAP for the pre-app and application to link together.
• PDF upload filenames are very specific and must be exact.

Submitting the ISP

• Enter a new ISP in REDCap and contact the appropriate grants officer to obtain the correct checklist for the specific funding opportunity.
• Submitters must use two sets of instructions – the funding announcement and the guidelines.
• When creating budget in SIMS, enter the word “Army” in the Sponsor field to query, then choose U.S. Army Medical Research and Development Command.
• When creating the Grants.Gov proposal in Cayuse, use the log number acquired during the pre-application process in the “Proposal Name” field.
• Also enter the log number in 4.a. “Federal Identifier” field.
• Select Thomas Brydebell as the Authorized Representative using email address of e-grants@pennstatehealth.psu.edu.
• When importing budget into Cayuse, select ALL for Base Salary Information Inclusion.
  • Note: This will produce a warning in Cayuse that says “[Budget period 1 A, Key Person 1][Cayuse] Base Salary is not equal to either Calendar Salary or Academic +Summer Salary. Is this your intention?” This is OK.
  • The Department of Defense does not utilize the NIH salary cap unless specifically stated in the guidelines. Use full salaries.
  • On the “Senior/Key Personnel” page, the Credential Agency Login is the username from the eReceipt system (used for pre-app), not the eRACommons username.
  • NIH bios can be used, or the Department of Defense form.
  • Department of Defense applications require detailed “other support” sections (more than for NIH; see specific guidelines for each application).

  Submission

  • After the Office of Research Affairs submits, the principal investigator will receive an email to log into eBRAP and verify application.
  • Not all pre-applications will be invited to submit a full proposal; check with the principal investigator for status.

  Any questions can be directed to the departmental grants officer.

  Revisions

  Last updated Aug. 7, 2019

Many University systems across the College of Medicine will automatically send emails to @psu.edu email addresses.

Faculty or staff who do not regularly check their @psu.edu email separately should make sure they have set up their @psu.edu email to forward to their @pennstatehealth.psu.edu address.

To set up this forward:

• Visit accounts.psu.edu and log in with the appropriate Penn State Access ID (generally the format xyz123@psu.edu)
• On the Accounts Management page, select the envelope icon on the left side taskbar.
• Under email forwarding, verify your @pennstatehealth.psu.edu email is listed. If not listed, click the toggle button “Forward my email to another provider”. Once toggled, it will change to blue.
• Under Forwarding Address, type your @pennstatehealth.psu.edu email (such as jsmith@pennstatehealth.psu.edu).
• Scroll to the bottom of the page and click yellow “Save” button. Test the forwarding by emailing your @psu.edu email from a personal (non-work) email address and making sure it appears in the @pennstatehealth.psu.edu email.

This tool can be used to calculate person-months for different spans of time based on percent effort.

• Enter the percent effort in the first box (required).
• Optionally, enter the annual salary in the second box.
• Hit calculate.

The appropriate person-months (and salaries, if applicable) will be displayed for 3-month, 6-month, 10-month and 12-month spans.

University Resources

• Export compliance guidelines
• Fringe and F&A rates
• Intellectual property information
• My Research Portal
• Professional development opportunities in research administration
• University policies

College of Medicine Resources

• Clinical Research Guidebook
• Clinical Trials Office
• Conflict of Interest Program
• Core Facilities
• Institutional Review Board/Human Subjects Protection Office
• Research Development

External Resources

• eRA Commons
• MyNCBI
• PubMed
• Proposal Central

The Office of Research Affairs maintains a directory of contact information by department for those people who are part of the pre-award and post-award grant and contract support process at Penn State College of Medicine.

This includes Office of Research Affairs personnel as well as departmental pre- and post-award teams.

See contacts by department